Kornimate/medical-research-clean huggingface dataset:
evaluating the efficacy and safety of extended release hydromorphone (exalgo) in patients with neuropathic pain

Conditions: Neuropathic Pain

Summary: the purpose of this study is to find out if exalgo (r) is beneficial for the patients with neuropathic pain.

neuropathic pain state is usually refractory to most analgesic regimens and requires polypharmacy for symptomatic relief. current treatment options for neuropathic pain include both oral and topical medications. most commonly prescribed oral treatments include antidepressants (eg, amitriptyline, desipramine, and duloxetine), antiepileptics (eg, gabapentin, pregabalin), and opiates such as tramadol and morphine. current topical treatments include the lidocaine patch and the capsaicin patch. many patients have inadequate pain relief in spite of these treatment options. currently, there are no treatments available for treatment of neuropathy itself other than treating the underlying cause and addressing the symptomatic relief for pain. current drug therapies for neuropathic pain provide inadequate pain relief and undesirable side effects including sedation and cognitive dysfunction. it is not uncommon to use a combination of agents for the treatment of neuropathic pain to minimize the side effects. although treating the mild to moderate pain may be relatively easy, it is very challenging for severe neuropathic pain. although the use of opiates for neuropathic pain is well accepted, it remains controversial because of the potential for abuse and diversion.

Eligibility criteria:
inclusion criteria: 1. individuals with chronic pain of more than 6 months duration 2. pain is determined to be secondary to a documented neuropathy 3. patients who are tolerant of opiates (60 mg of morphine or equivalent for at least one week) 4. male or female patients aged 18-75 yrs and have signed a written informed consent form and privacy statement 5. female patients of child-bearing potential must be using an acceptable form of birth control exclusion criteria: 1. pregnant or lactating women 2. allergy to morphine or its derivatives 3. history of alcohol or substance abuse in the last 3 yrs 4. participation in any other clinical trial in the last 30 days 5. uncontrolled pain 6. patient who is deemed to be medically unstable by principal investigator 7. history of severe lung disease or asthma that is deemed medically significant by principal investigator

Keywords: pain neuropathy neuropathic pain hydromorphone
sweden cancerome analysis network - breast : genomic profiling of breast cancer

Conditions: Breast Neoplasms

Summary: this study evaluates the genomic profiles of breast cancer in a prospective and population-based manner. in the first phase, breast tumors are analyzed by whole transcriptome rna-sequencing. gene expression profiles, mutational profiles, and transcript isoform-level data will be analyzed in the context of patient information, clinicopathological variables, and outcome, with the purpose to develop new molecular diagnostic assays for breast cancer. additional genome-scale rna, dna, and protein analyses will be performed in the future.

breast cancer exhibits significant molecular, pathological, and clinical heterogeneity. current patient and clinicopathological evaluation is imperfect for predicting outcome, which results in overtreatment for many patients, and for others, leads to death from recurrent disease. therefore, additional criteria are needed to better personalize care and maximize treatment effectiveness and survival. the sweden cancerome analysis network - breast (scan-b) study was initiated in 2010 as a multicenter prospective population-based observational study with long-sighted aims to analyze breast cancers with next-generation genomic technologies for translational research and integrated with healthcare; decipher fundamental tumor biology from these analyses; utilize genomic data to develop and validate new clinically-actionable biomarker assays; and establish real-time clinical implementation of molecular diagnostic, prognostic, and predictive tests. in the first phase, we focus on molecular profiling by next-generation rna-sequencing. gene expression profiles, mutational profiles, and transcript isoform-level data will be analyzed in the context of patient information, clinicopathological variables, and outcome, with the purpose to develop new molecular diagnostic assays for breast cancer. additional genome-scale rna, dna, and protein analyses will be performed in the future. as of february 2024, over 20,000 patients have enrolled in the study, representing approximately 85% of all eligible patients within the catchment region. tissue and blood collection is integrated within healthcare routines and clinical information is provided from national quality registries. as of q4 2021, the scan-b rna-seq analysis for molecular subtyping and risk-of-recurrence has been clinically implemented for all breast cancer patients in skåne within the center for molecular diagnostics, laboratory medicine, medical service, region skåne.

Eligibility criteria:
inclusion criteria: * suspicion or confirmed diagnosis of primary breast cancer * signed informed consent exclusion criteria: * lack of signed informed consent

Keywords: prognostic and predictive biomarkers rna-sequencing pathological complete response minimal residual disease molecular subtype gene expression profiling mutation screening brca translational research genomics transcriptomics proteomics metabolomics liquid biopsy circulating tumor cells circulating tumor dna rna-seq
intravenous tramadol and magnesium sulphate for prevention of shivering

Conditions: Lower Extremity Chronic Venous Ulcers; Varicose Veins Leg; Hernia

Summary: the aim of this work was to compare the efficacy of intravenous (iv) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia.


Eligibility criteria:
inclusion criteria: - american society of anesthesiologists (asa) i and ii physical status undergoing an elective surgery under spinal anesthesia. exclusion criteria: * history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever \&gt;38 celsius or less than 36 celsius, body mass index more than 35 and who has history of alcohol intake

Keywords: tramadol magnesium sulphate shivering
monitoring of early disease progression in hereditary transthyretin amyloidosis

Conditions: Amyloidosis; Amyloid; Amyloid Neuropathies, Familial; Amyloid Cardiomyopathy; Amyloid - Primary; Transthyretin Amyloidosis; AL Amyloidosis

Summary: this study measures circulating, misfolded attr oligomers in asymptomatic attrm amyloidosis genetic carriers longitudinally over five years.

recent advances in genetic testing have allowed for pathogenic mutation identification in family members of affected individuals prior to onset of symptoms. while the presence of mutation and the corresponding ttr kinetic stability have been directly linked to disease development, the molecular drivers of tissue specific degeneration have not been defined. we hypothesize that soluble misfolded ttr oligomer species may be circulating within the blood of these patients possibly years prior to amyloid deposition and could serve as an early biomarker and/or driver for disease development. in this line, the scripps research institute has developed a peptide-based probe that specifically labels and integrates into misfolded ttr oligomers allowing the relative circulating concentration in the bloodstream to be determined. longitudinal monitoring of untreated, asymptomatic ttr amyloid genetic carriers utilizing the scripps probe is likely to provide novel insight into early disease progression. we also plan to utilize the scripps probe to monitor disease progression in ttr amyloid genetic carriers currently undergoing treatment by observing how treatments affect the circulating misfolded ttr oligomers. through enhanced understanding of early disease progression and treatment efficacy, our hope is to limit amyloid accumulation in cardiac and nerve tissue and delay the development of the invariably fatal ttr amyloid cardiomyopathy/neuropathy.

Eligibility criteria:
inclusion criteria: * patients with known hereditary attr amyloidosis genetic mutations as identified by genetic testing. exclusion criteria: * patients with attr amyloidosis identified as wild-type.
effects of inspiratory muscle training in addition to pulmonary rehabilitation in patients with copd exacerbation

Conditions: Exacerbation Copd

Summary: inspiratory muscle weakness, limited functional exercise capacity and worse quality of life have been shown in patients with exacerbation of chronic obstructive pulmonary disease (copd). recommendations from clinical practice guideline state that promoting pulmonary rehabilitation after exacerbation can improve the conditions above. inspiratory muscle training (imt) has been proven to enhance inspiratory muscle strength and endurance in patient with stable copd. however, there is less research on whether imt in addition to pulmonary rehabilitation after exacerbation can benefit inspiratory muscle function, functional exercise capacity and quality of life in patients with copd. the purpose of this study is to examine the effects of imt in addition to pulmonary rehabilitation on respiratory muscle function, functional exercise capacity and quality of life in patients with exacerbation of chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * age \> 20 years old * diagnosed as exacerbation of copd * maximal inspiratory pressure (mip) \< 80 cmh2o exclusion criteria: * any clinical diagnosis that will influence the measurement, including any history of neuromyopathy * angina, acute myocardial infarction in the previous one month * pregnancy * participated in inspiratory muscle training program in the previous three months * any psychiatric or cognitive disorders, for example: mini-mental state examination (mmse) \< 24, that will disturb the communication and cooperation of the study
the clinical evaluation of two daily disposable contact lenses

Conditions: Myopia

Summary: the objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.


Eligibility criteria:
inclusion criteria: * they are of legal age (18 years) and capacity to volunteer. * they understand their rights as a research subject and are willing to sign a statement of informed consent. * they are willing and able to follow the protocol. * they would be expected to attain at least 6.9 (20/30) in each eye with the study lenses. * they are able to wear contact lenses which have a back vertex power of -1.00 to -6.00ds. * they have a maximum of 1.00d of refractive astigmatism (i.e. \< 1.00 dc). * they have worn soft contact lenses within six months of starting the study. exclusion criteria: * they have an ocular disorder which would normally contra-indicate contact lens wear. * they have a systemic disorder which would normally contra-indicate contact lens wear. * they are using any topical medication such as eye drops or ointment. * they are aphakic. * they have had corneal refractive surgery. * they have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. * they are pregnant or lactating. * they have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. * they have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., hiv). * they have diabetes. * they are currently taking part in any other clinical study or research.
the association between human microbiome and vitamin d in chronic urticaria

Conditions: Urticaria

Summary: a double-blind study to evaluate the role of human microbiome and vitamin d in the development of urticaria.

urticaria is a chronic allergic inflammatory disorder. genetic and environmental factors, such as exposure to allergens and microbes, have a detrimental role in the development of chronic urticaria. vitamin d also has an important role in urticaria. lower sera vitamin d level was observed in patients that developed urticaria. vitamin d binding protein (dbp) bound to vitamin d and regulated its metabolites in the circulation. moreover, vitamin d receptors (vdr) have been identified on nearly all cells of the immune system. it may contribute to maintenance of intestinal barrier function by preventing increased intestinal permeability, dysbiosis, inflammation, and a lack of immune tolerance in the gut. the investigators plan to design a double-blind trial to evaluate the role of human microbiome and vitamin d in the development of urticaria. we will enroll children with chronic urticaria (cu) and age and gender matched healthy children,and collected their venous blood and microbiome samples of nasal and anal swab. then, cu subjects will be given vitamin d or placebo for 6 months in a randomized, double-blind way. after six months of follow-up, their blood, nasal cavity, and intestinal bacterial samples were taken. all microbial analysis, allergen detection, vitamin d concentration, vdr, dbp genotype will be analyzed by the core laboratory and bioinformatics center of cmuh. the investigators believe this study can answer the cause-effect relationships of microbiota and vitamin d in the development of cu, and design a microbiota-related preventive and treatment strategy.

Eligibility criteria:
inclusion criteria: 1. experimental group: patients with chronic spontaneous urticaria under the age of 18 . 2. control group: healthy children under the age of 18 (eg, healthy siblings of sick children). exclusion criteria: 1. recruit patients who have used antibiotics, systemic steroids, and immunosuppressants in the previous month. 2. patients with c1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia, severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune disease.

Keywords: vitamin d human microbiome vitamin d receptors and vitamin d binding protein
vr-based intervention for cognitive restoration

Conditions: Breast Cancer; Cognitive Dysfunction; Virtual Reality

Summary: the aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women treated for breast cancer.

cognitive dysfunction is a kind of cluster of commonly reported neurotoxic symptoms following cancer diagnosis and treatment, especially chemotherapy. our previous studies found that breast cancer patients and survivors had greater difficulties in performing attention, working memory, and executive function tasks and had persistent neural inefficiency of an executive network of the brain than disease and treatment counterparts. the aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women with cognitive complaints after breast cancer treatment. all participants will receive the initial screening to verify their cognitive status and then will be randomly assigned to the experimental or control group. the experimental group will receive a 4-week cognitive intervention by using a vr headset. each vr content includes 10-12 video scenes with visual and auditory stimuli that were generated from nature.

Eligibility criteria:
inclusion criteria: * being treated with chemotherapy for breast cancer * having affirmative responses to three questions about cognitive problems and their impact on daily performance * having fact-cog scores of 58 or less * having mini-cog scores of 3 and higher * having the ability to read, understand or respond to questionnaires and cognitive assessment * being willing to participate and able to provide written informed consent exclusion criteria: * having metastatic breast cancer * having patient health questionnaire-2 score of 3 and higher * being diagnosed with neurological disorders such as dementia, multiple sclerosis, or traumatic brain injury * having epilepsy or seizure * having 'quite a bit' or 'extremely' severe level of nausea and vomiting * having visual or hearing impairments * having other problems that prevent them from wearing the vr headset
evaluation of computer-guided secondary alveolar cleft bone grafting with and without platelet-rich fibrin

Conditions: Alveolar Bone Grafting

Summary: this study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. this grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested.


Eligibility criteria:
inclusion criteria: 1. healthy patients who are classified according to the american society of anesthesiologists (asa) physical status classification as class i. 2. patients seeking treatment and accepting to be enrolled in the study, so as their guardians. 3. patients who will age 9-14 years old by the surgery day. 4. patients with adequate chin bone volume that could be harvested without marked donor site morbidity, as pre-determined by cone beam computed tomography. exclusion criteria: 1. patients with systemic illness, i.e. asa(22) classes ii, iii, iv, and v. 2. patients with previously operated alveolar clefts and seeking revision for the same cleft. 3. patients that wouldn't be able to attend the recalls. 4. patients with other craniofacial anomalies and associated syndrome conditions. 5. edentulous maxilla, atypical or non-described cleft diagnosis. 6. patients with history of chemotherapy or radiotherapy.
pass study to evaluate the potential of zithromax to cause ocular problems in pediatric patients

Conditions: Pharyngitis; Tonsillitis

Summary: this post-authorization safety study (pass) is intended to fulfill a regulatory post-marketing requirement to provide data regarding visual abilities in children taking azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. the primary objective of the study is to examine the incidence of clinically significant worsening in any of the following ophthalmic exams: best corrected visual acuity (distance), color vision, amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of approximately 30 pediatric patients taking azithromycin oral solution for treatment of an authorized indication of use (pharyngitis/ tonsillitis).

study was terminated prematurely on october 16, 2015 following fda decision to release sponsor from post-marketing commitment. no safety and/or efficacy concerns identified.

Eligibility criteria:
inclusion criteria: * male or female patient, aged 12 to 17 years. * requires outpatient treatment for acute pharyngitis/tonsillitis infection. * appropriate to treat with oral azithromycin as an alternative to intramuscular penicillin, in the opinion of the investigator. * positive rapid antigen detection test. exclusion criteria: * history of clinically significant eye disorder that would interfere with protocol test procedures. * hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic. * increased risk of qt prolongation. * pregnant or breastfeeding.

Keywords: ocular safety azithromycin pharyngitis tonsillitis
identification the cause of cerebral infarction in patients with cancer

Conditions: Cryptogenic Embolic Stroke; Active Cancer

Summary: although there has been increasing interest in the association between cancer and cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still not fully understood. the aim of this study is to investigate the stroke mechanisms in patients with cancer-associated stroke.

patients with cryptogenic embolic stroke will be prospectively enrolled and categorized into two groups according to the presence of active cancer: cryptogenic embolic stroke with active cancer (cancer-associated stroke) vs. without active cancer (cryptogenic embolic stroke). all patients will undergo brain mri/mra, 12-lead electrocardiography, transthoracic and transesophageal echocardiography with injection of agitated saline, and 24-hour holter and/or telemonitoring. duplex ultrasonography to detect venous thrombosis of the lower extremity will also be performed in patients with a positive right-to-left shunt on echocardiography.

Eligibility criteria:
inclusion criteria: * subjects with acute ischemic stroke who presented within 7 days from symptom onset * subjects who had embolic infarction outside the perforator territory revealed by diffusion-weighted imaging * subjects with undetermined cause of stroke despite of initial evaluation including electrocardiogram and brain imaging upon admission * subjects who performed brain magnetic resonance image (mri) and mr angiography (mra), cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal echocardiography with injection of agitated saline (or agitated saline transcranial doppler monitoring), and 24-hour holter and/or telemonitoring) * subjects with informed consent exclusion criteria: * subjects with single subcortical infarction * subjects with primary brain tumor * inability to perform comprehensive studies * refusal or withdrawal of the consent
pharmacokinetics and bioavailability of pomegranate phenolics and urolithins in healthy subjects.

Conditions: Healthy

Summary: pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly uro-a). both ellagic acid (ea) and urolithins can exert a number of biological activities. however, the bioavailability of ellagic acid has been reported to be very low and the existing studies are controversial so far. the investigators want to carry out a robust (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of pomegranate extracts (pes). pes with low (pe-1) and high (pe-2) punicalagin:ea ratio will be administered. the investigators will analyze blood and urine samples using uplc-esi-qtof-ms/ms. the investigators will evaluate: * the pharmacokinetics of ea. * the effect of punicalagin:free ea ratio on the pharmacokinetics of ea and urolithins production.


Eligibility criteria:
inclusion criteria: * aged 18-35 years. * healthy status (no illness in the previous 3-months). exclusion criteria: * smoking. * pregnancy/lactation. * severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, crohn disease etc.). * previous gastrointestinal surgery * recent use of antibiotics (within 1-month prior to the study) * suspected hypersensitivity to pomegranate or any of its components * consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication. * regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire). * intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.

Keywords: pomegranate ellagic acid pharmacokinetics urolithins bioavailability